Whether you’re a doctor checking on the devices you use, a manufacturer learning from others’ mistakes, or you just like drama, you need to know about recent FDA medical device recalls. Every year, the FDA gets 2+ million reports of deaths, injuries, and malfunctions suspected of being linked to medical devices. The agency then issues recalls with corrections ranging from making tweaks to pulling a device off the market. Healthcare Brew provides a monthly summary of some recent Class I recalls, the most dangerous kind. Without further ado, here is September’s Recall Roundup! Bent out of shape. Several components of Medtronic Cardiac Surgery’s DLP left heart ventricle catheter have been recalled because the catheters “may not retain their shape.” Medtronic told users to quarantine affected lots. See the full list here.—CC |